Coronary Artery Bypass GraftingNCT07299760
Analgesic Efficacy of Parasternal Block Versus Parasternal Plus Serratus Anterior Plane Block After Coronary Bypass Surgery
A study testing parasternal block and parasternal block + serratus anterior plane block in people with Coronary Artery Bypass Grafting, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This single-centre randomized clinical trial will compare two regional anaesthesia techniques for postoperative pain control in adult patients undergoing elective coronary artery bypass grafting (CABG) with sternotomy. All patients will receive a bilateral parasternal block as part of routine multimodal analgesia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Bypass Grafting
- What is being tested?
- parasternal block and parasternal block + serratus anterior plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- American Society of Anesthesiologists (ASA) physical status III-IV
- Scheduled for elective coronary artery bypass grafting surgery with sternotomy for coronary artery disease
- Able to provide written informed consent
Who cannot join
- Allergy or contraindication to local anaesthetic agents
- Minimally invasive bypass surgery or off-pump procedures planned
- Emergency cardiac surgery
- Preoperative Numeric Rating Scale (NRS) pain score ≥ 3
- Chronic opioid use in the preoperative period
- Infection or structural abnormality at planned block sites
- Any condition preventing postoperative pain assessment or PCA use (e.g. severe cognitive impairment)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Etlik City Hospital
Yenimahalle, Ankara, 06810
About this study
Official title: Evaluation of the Analgesic Efficacy of Parasternal Block and Parasternal Plus Serratus Anterior Plane Block in Patients Undergoing Coronary Artery Bypass Grafting Surgery
This single-centre randomized clinical trial will compare two regional anaesthesia techniques for postoperative pain control in adult patients undergoing elective coronary artery bypass grafting (CABG) with sternotomy. All patients will receive a bilateral parasternal block as part of routine multimodal analgesia. Patients will be randomized to receive either parasternal block alone or a combination of parasternal block and serratus anterior plane block. The primary objective is to evaluate whether adding a serratus anterior plane block improves postoperative pain scores compared with parasternal block alone. Secondary objectives include comparing opioid consumption, need for rescue analgesics, opioid-related side effects, and length of stay in the intensive care unit and hospital.
Read the detailed description
Background: Postoperative pain after coronary artery bypass surgery arises from both the sternotomy incision and the chest tube insertion sites and may impair mobilisation, deep breathing, and coughing. Fascial plane blocks of the chest wall, such as parasternal block and serratus anterior plane block, are increasingly used because they are technically simple and have a low complication risk. Previous observational data suggested that combining bilateral parasternal block and serratus anterior plane block provides effective analgesia after CABG, but sample size was small and no randomized comparison has been performed.
Objectives: The primary objective is to compare postoperative pain intensity between parasternal block alone and parasternal plus serratus anterior plane block in adult patients undergoing elective CABG with sternotomy. Secondary objectives are to compare total opioid consumption (tramadol via patient-controlled analgesia), need for rescue analgesics, incidence of opioid-related adverse events (e.g. nausea and vomiting), and intensive care unit and hospital length of stay between the two groups.
Methods: This is a prospective, randomized, parallel-group, low-risk interventional study conducted in the Anaesthesiology and Reanimation Department of Ankara Etlik City Hospital. Adult patients (≥18 years) scheduled for elective coronary bypass surgery due to coronary artery disease and classified as ASA II-IV will be screened for eligibility. After induction of general anaesthesia and before surgical incision, all patients will receive an ultrasound-guided bilateral parasternal block. Patients randomized to the experimental arm will additionally receive a bilateral serratus anterior plane block. Local anaesthetic dosing will follow routine clinical practice, with a total dose not exceeding 2 mg/kg of 0.25% bupivacaine. All patients will receive 40 ml of 0.25% bupivacaine. The parasternal group will receive a bilateral parasternal block via administering 20 ml of 0.25% bupivacaine bilaterally. The parasternal+serratus anterior plane block group will receive 10 ml of 0.25% bupivacaine to bilateral parasternal and deep serratus planes.
Pain intensity will be assessed using the Numeric Rating Scale (NRS, 0-10) at extubation (T0) and postoperative 4, 6, 12, and 24 hours (T4, T6, T12, T24). Postoperative analgesia will include standard intravenous acetaminophen and tramadol via patient-controlled analgesia; total tramadol dose (demand and delivered), rescue analgesic requirement, and adverse events will be recorded in the first 24 postoperative hours.
Sample size: Based on a two-group comparison with an effect size of 0.6, α = 0.0,5, and β = 0.2, 72 patients are required to achieve 80% power.
- Conditions
- Coronary Artery Bypass Grafting
- Being tested
- parasternal block, parasternal block + serratus anterior plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parasternal blockProcedure or surgery
After induction of general anaesthesia and before skin incision, an ultrasound-guided bilateral parasternal intercostal plane block will be performed. A linear ultrasound probe will be placed parasagittally at the 2nd and 4th intercostal spaces approximately 2-3 cm lateral to the sternum. A block needle will be advanced in-plane beneath the pectoralis major muscle and above the internal intercostal muscles, and local anaesthetic (0.25% bupivacaine) will be injected bilaterally. Total dose will not exceed 2 mg/kg. Postoperative systemic analgesia (patient-controlled analgesia) will be identical in both groups.
parasternal block + serratus anterior plane blockProcedure or surgery
In addition to the bilateral parasternal block described for the comparator arm, patients randomized to the experimental arm will receive an ultrasound-guided bilateral serratus anterior plane block. With the patient in supine position, the linear ultrasound probe will be placed over the 6th rib in the anterior axillary line. The needle will be advanced in-plane beneath the serratus anterior muscle and above the rib, and 0.25% bupivacaine will be injected into the fascial plane on each side. The combined total dose of local anaesthetic for both blocks will not exceed 2 mg/kg. Postoperative systemic analgesia will be identical in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Parasternal Block | Active comparator | After induction of general anaesthesia and before skin incision, an ultrasound-guided bilateral parasternal intercostal plane block will be performed. Receives: Procedure: parasternal block |
| Arm B: Serratus Anterior Plane Block | Experimental | In addition to the bilateral parasternal block described for the comparator arm, patients randomized to the experimental arm will receive an ultrasound-guided bilateral serratus anterior plane block. Receives: Procedure: parasternal block; Procedure: parasternal block + serratus anterior plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Tramadol Consumption
Cumulative dose of tramadol (mg) delivered by patient-controlled analgesia (PCA) in the first 24 hours post-extubation
Measured: 24-hour post-extubation
Secondary outcomes (2)
Resting Numeric Rating Scale (NRS) Pain Score
NRS score during rest (0= no pain, 10= worst imaginable pain)
Measured: 24 hour post-extubation
Dynamic Numeric Rating Scale (NRS) Pain Score
NRS score during coughing or deep inspiration (0= no pain, 10= worst imaginable pain)
Measured: 24-hour post-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Sep 2025
- Primary completion1 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekin Guran, MD, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299760
- Sponsor's protocol ID
- PS_SAPB
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the primary publication may be shared upon reasonable request to the principal investigator after publication of the results.
Publications
Zengin EN, Yigit H, Cobas M, Salman N, Asli Demir Z. The analgesic effects of combined bilateral parasternal block and serratus anterior plane block for coronary artery bypass grafting surgery. BMC Anesthesiol. 2024 Aug 5;24(1):274. doi: 10.1186/s12871-024-02659-7.
PubMed 39103782
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesic Efficacy of Parasternal Block and Parasternal Plus Serratus Anterior Plane Block in Patients Undergoing Coronary Artery Bypass Grafting Surgery
- ClinicalTrials.gov ID
- NCT07299760
- Acronym / sponsor ID
- PS_SAPB
- Conditions
- Coronary Artery Bypass Grafting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-centre randomized clinical trial will compare two regional anaesthesia techniques for postoperative pain control in adult patients undergoing elective coronary artery bypass grafting (CABG) with sternotomy. All patients will receive a bilateral parasternal block as part of routine multimodal analgesia. Patients will be randomized to receive either parasternal block alone or a combination of parasternal block and serratus anterior plane block. The primary objective is to evaluate whether adding a serratus anterior plane block improves postoperative pain scores compared with parasternal block alone. Secondary objectives include comparing opioid consumption, need for rescue analgesics, opioid-related side effects, and length of stay in the intensive care unit and hospital.
Detailed description
Background: Postoperative pain after coronary artery bypass surgery arises from both the sternotomy incision and the chest tube insertion sites and may impair mobilisation, deep breathing, and coughing. Fascial plane blocks of the chest wall, such as parasternal block and serratus anterior plane block, are increasingly used because they are technically simple and have a low complication risk. Previous observational data suggested that combining bilateral parasternal block and serratus anterior plane block provides effective analgesia after CABG, but sample size was small and no randomized comparison has been performed.
Objectives: The primary objective is to compare postoperative pain intensity between parasternal block alone and parasternal plus serratus anterior plane block in adult patients undergoing elective CABG with sternotomy. Secondary objectives are to compare total opioid consumption (tramadol via patient-controlled analgesia), need for rescue analgesics, incidence of opioid-related adverse events (e.g. nausea and vomiting), and intensive care unit and hospital length of stay between the two groups.
Methods: This is a prospective, randomized, parallel-group, low-risk interventional study conducted in the Anaesthesiology and Reanimation Department of Ankara Etlik City Hospital. Adult patients (≥18 years) scheduled for elective coronary bypass surgery due to coronary artery disease and classified as ASA II-IV will be screened for eligibility. After induction of general anaesthesia and before surgical incision, all patients will receive an ultrasound-guided bilateral parasternal block. Patients randomized to the experimental arm will additionally receive a bilateral serratus anterior plane block. Local anaesthetic dosing will follow routine clinical practice, with a total dose not exceeding 2 mg/kg of 0.25% bupivacaine. All patients will receive 40 ml of 0.25% bupivacaine. The parasternal group will receive a bilateral parasternal block via administering 20 ml of 0.25% bupivacaine bilaterally. The parasternal+serratus anterior plane block group will receive 10 ml of 0.25% bupivacaine to bilateral parasternal and deep serratus planes.
Pain intensity will be assessed using the Numeric Rating Scale (NRS, 0-10) at extubation (T0) and postoperative 4, 6, 12, and 24 hours (T4, T6, T12, T24). Postoperative analgesia will include standard intravenous acetaminophen and tramadol via patient-controlled analgesia; total tramadol dose (demand and delivered), rescue analgesic requirement, and adverse events will be recorded in the first 24 postoperative hours.
Sample size: Based on a two-group comparison with an effect size of 0.6, α = 0.0,5, and β = 0.2, 72 patients are required to achieve 80% power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Parasternal Block | Active comparator | Procedure: parasternal blockAfter induction of general anaesthesia and before skin incision, an ultrasound-guided bilateral parasternal intercostal plane block will be performed. |
| Arm B: Serratus Anterior Plane Block | Experimental | Procedure: parasternal block, Procedure: parasternal block + serratus anterior plane blockIn addition to the bilateral parasternal block described for the comparator arm, patients randomized to the experimental arm will receive an ultrasound-guided bilateral serratus anterior plane block. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- American Society of Anesthesiologists (ASA) physical status III-IV
- Scheduled for elective coronary artery bypass grafting surgery with sternotomy for coronary artery disease
- Able to provide written informed consent
Key exclusion criteria (7 listed)
- Allergy or contraindication to local anaesthetic agents
- Minimally invasive bypass surgery or off-pump procedures planned
- Emergency cardiac surgery
- Preoperative Numeric Rating Scale (NRS) pain score ≥ 3
- Chronic opioid use in the preoperative period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| parasternal blockAfter induction of general anaesthesia and before skin incision, an ultrasound-guided bilateral parasternal intercostal plane block will be performed. A linear ultrasound probe will be placed parasagittally at the 2nd and 4th intercostal spaces approximately 2-3 cm lateral to the sternum. A block needle will be advanced in-plane beneath the pectoralis major muscle and above the internal intercostal muscles, and local anaesthetic (0.25% bupivacaine) will be injected bilaterally. Total dose will not exceed 2 mg/kg. Postoperative systemic analgesia (patient-controlled analgesia) will be identical in both groups. | Procedure or surgery | Arm A: Parasternal Block, Arm B: Serratus Anterior Plane Block |
| parasternal block + serratus anterior plane blockIn addition to the bilateral parasternal block described for the comparator arm, patients randomized to the experimental arm will receive an ultrasound-guided bilateral serratus anterior plane block. With the patient in supine position, the linear ultrasound probe will be placed over the 6th rib in the anterior axillary line. The needle will be advanced in-plane beneath the serratus anterior muscle and above the rib, and 0.25% bupivacaine will be injected into the fascial plane on each side. The combined total dose of local anaesthetic for both blocks will not exceed 2 mg/kg. Postoperative systemic analgesia will be identical in both groups. | Procedure or surgery | Arm B: Serratus Anterior Plane Block |
Primary outcome
Total Tramadol Consumption
Time frame: 24-hour post-extubation
Cumulative dose of tramadol (mg) delivered by patient-controlled analgesia (PCA) in the first 24 hours post-extubation
2 secondary outcomes
Resting Numeric Rating Scale (NRS) Pain Score
Time frame: 24 hour post-extubation
Dynamic Numeric Rating Scale (NRS) Pain Score
Time frame: 24-hour post-extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Results publication: PubMed 39103782Zengin EN, Yigit H, Cobas M, Salman N, Asli Demir Z. The analgesic effects of combined bilateral parasternal block and serratus anterior plane block for coronary artery bypass grafting surgery. BMC Anesthesiol. 2024 Aug 5;24(1):274. doi: 10.1186/s12871-024-02659-7.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the primary publication may be shared upon reasonable request to the principal investigator after publication of the results.
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Coronary Artery Bypass Graft (CABG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parasternal block and parasternal block + serratus anterior plane block in people with Coronary Artery Bypass Grafting, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Tramadol Consumption (time frame: 24-hour post-extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07299760, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.